Clinical trial for Recurrent Ovarian Cancer
Official title Combination Therapy for Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT05610735
What this study is testing
What is DOXIL?
DOXIL is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for recurrent ovarian cancer.
Also referred to as Liposomal doxorubicin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The proposed study "combination therapy with liposomal doxorubicin and withaferin A (Ashwagandha, ASWD) in recurrent ovarian cancer" is focused to determine the feasibility and maximum tolerance dose of Ashwagandha with liposomal doxorubicin (DOXIL) in recurrent ovarian cancer patients. The study contains two parts.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients with recurrent ovarian/fallopian tube/primary peritoneal cancer for whom liposomal Doxorubicin would be an acceptable therapeutic option...
- Signed approved informed consent document stating that they understand the investigational nature of the treatment program before entering study
- Female patients, age ≥ 18 years
- Pathological confirmed ovarian, fallopian tube, or primary peritoneal carcinoma with the one of the following histologic types: high grade papillary...
- Received at least one line chemotherapy, which must be a platinum containing regimen and develop platinum resistance. Patients may have not received...
You likely can't join if
- Patients will be excluded from the study if they meet any of the following criteria:
- ECOG performance status 3 or 4
- Pregnant or breastfeeding
- Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5...
- Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule...
- Patients with known pericardial effusion
See the full eligibility criteria
Who can join
- Patients with recurrent ovarian/fallopian tube/primary peritoneal cancer for whom liposomal Doxorubicin would be an acceptable therapeutic option will be recruited. Patients are eligible if they have received first line...
- Signed approved informed consent document stating that they understand the investigational nature of the treatment program before entering study
- Female patients, age ≥ 18 years
- Pathological confirmed ovarian, fallopian tube, or primary peritoneal carcinoma with the one of the following histologic types: high grade papillary serous carcinoma, low grade papillary serous carcinoma, high grade...
- Received at least one line chemotherapy, which must be a platinum containing regimen and develop platinum resistance. Patients may have not received previous liposomal doxorubicin therapy, and must be considered to be...
- Patients may have undergone surgical cytoreduction at the time of primary diagnosis or following neoadjuvant chemotherapy. Patients who had optimal (\ 1 cm residual disease) following surgical cytoreduction will be...
- Recurrent disease confirmed by biopsy, radiologic imaging, and/or elevated CA 125
- Patients may have received radiation therapy
- Life expectancy \> 6 months
- Part 1: Have evaluable disease by radiologic measurements (See 11) or CA 125
- Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as \> 1 cm on cross-sectional imaging (where the CT slice thickness...
- Adequate organ function within 14 days prior to first WFA/ASWD dose or liposomal doxorubicin whichever occurs first, including the following: absolute neutrophil count (ANC) ≥ 1.5 x 103/L, platelet count ≥ 100 x 103/L...
- Satisfy one of the following:
- Females: non-pregnant and non-lactating; surgically sterile, post- menopausal, or patient/partner compliant with a reliable contraceptive regimen, as determined by the investigator, for 4 weeks prior to screening.
- Patients of reproductive potential must test negative for pregnancy at screening, prior to each cycle, and must agree to use a reliable method of birth control during the study period and 6 months following completion...
- The patient is willing and able to comply with the study visit schedule and procedures and has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol
- For Part 1: Patients have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks prior to study treatment and have recovered from the acute...
- ECOG performance status of 0, 1, or 2
- Adequate ejection fraction determined by transthoracic echo or MUGA of at least 55%
- Patients may have received prior anthracycline or anthracenedione therapy. In this scenario, the use of prior treatments will be incorporated into the cumulative dose calculations when applicable, given a known...
What rules you out
- Patients will be excluded from the study if they meet any of the following criteria:
- ECOG performance status 3 or 4
- Pregnant or breastfeeding
- Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer
- Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients
- Patients with known pericardial effusion
- Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)
- Presence or history of malignancy other than ovarian cancer that does not include carcinoma in situ of the cervix, or non-melanoma skin cancer. In the case of other malignancies, patients may be considered for...
- Presence of an underlying disease state associated with active bleeding
- Concurrent treatment with other anticancer drugs
- Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device
- Patients with any other medical conditions that, in the opinion of the Investigator, would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study
- Patients with known septicemia, severe infection, or acute hepatitis
- Patients with known congestive heart failure or unstable angina or those who had a myocardial infarction within the past 6 months
- Patients with known clinically significant pericardial disease
- Patients taking medications known to affect the cardiac conduction system
- Allergy to WFA/ASWD
- Previous treatment with liposomal doxorubicin
- Prior use of other anthracyclines or anthracenediones -
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.